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A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

NCT ID: NCT01254656

Last Updated: 2014-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-04-30

Brief Summary

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This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.

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Detailed Description

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The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

Conditions

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HIV-1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LRV 500mg

Group Type EXPERIMENTAL

lersivirine

Intervention Type DRUG

Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

LRV 750mg +TVD

Group Type EXPERIMENTAL

lersivirine

Intervention Type DRUG

Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

EFV

Group Type ACTIVE_COMPARATOR

efavirenz

Intervention Type DRUG

Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

LRV 750mg+ DRV/r + OBT

Group Type EXPERIMENTAL

lersivirine

Intervention Type DRUG

Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI

LRV 1000mg +DRV/r + OBT

Group Type EXPERIMENTAL

lersivirine

Intervention Type DRUG

Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI

ETR

Group Type ACTIVE_COMPARATOR

etravirine

Intervention Type DRUG

Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI

Interventions

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lersivirine

Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

Intervention Type DRUG

lersivirine

Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

Intervention Type DRUG

efavirenz

Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

Intervention Type DRUG

lersivirine

Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI

Intervention Type DRUG

lersivirine

Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI

Intervention Type DRUG

etravirine

Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
* Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
* For women who can have children, a negative urine pregnancy test at the Day 1 visit.

Exclusion Criteria

* Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.
* Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

Pfizer Investigational Site

Melbourne, Victoria, Australia

Site Status

Pfizer Investigational Site

Nova Iguaçu, Rio de Janeiro, Brazil

Site Status

Pfizer Investigational Site

Toronto, Ontario, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Torino, , Italy

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Bydgoszcz, , Poland

Site Status

Pfizer Investigational Site

Warsaw, , Poland

Site Status

Pfizer Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Soweto, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Pfizer Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Pfizer Investigational Site

Pretoria, , South Africa

Site Status

Pfizer Investigational Site

Lugano, , Switzerland

Site Status

Pfizer Investigational Site

Sankt Gallen, , Switzerland

Site Status

Pfizer Investigational Site

Zurich, , Switzerland

Site Status

Pfizer Investigational Site

Brighton, East Sussex, United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Countries

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Australia Brazil Canada Italy Mexico Poland South Africa Switzerland United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271037&StudyName=A%20Long%20Term%20Safety%20Study%20Of%20Lersivirine%20For%20The%20Treatment%20Of%20HIV-1%20Infection%20In%20Subjects%20Who%20Have%20Completed%20Treatment%20With%20Lersivirine

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5271037

Identifier Type: -

Identifier Source: org_study_id

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